General & Plastic Surgery › SurgicalGouge, Surgical, General & Plastic Surgery

Sklar®

Buck Gramcko Gouge S CVD 5.25 Inches

Registry build 21.09.26
4manufacturers in China registered for this device type
206catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GDH
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106

Record

Regulatory record for Sklar®
Listed by Sklar Corporation, United States
FDA product code GDH
Device type Gouge, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-04-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Sklar®
Catalogue number Size Status
40-6908 In distribution
40-6348 In distribution
93-1329 In distribution
40-6802 In distribution
40-3256 In distribution
40-5985 In distribution
40-6864 In distribution
40-6393 In distribution
40-6869 In distribution
40-6384 In distribution
40-6837 In distribution
40-6050 In distribution
40-6697 In distribution
40-3247 In distribution
40-6312 In distribution
40-7188 In distribution
40-6828 In distribution
40-6830 In distribution
40-6448 In distribution
40-6833 In distribution
40-6861 In distribution
40-6892 In distribution
40-6073 In distribution
40-6898 In distribution
40-3262 In distribution
40-6060 In distribution
40-6395 In distribution
40-3244 In distribution
40-6079 In distribution
40-6439 In distribution
40-6442 In distribution
40-6906 In distribution
40-6805 In distribution
40-6699 In distribution
40-6392 In distribution
40-6342 In distribution
40-6893 In distribution
40-6443 In distribution
40-6849 In distribution
40-6310 In distribution
40-3243 In distribution
40-6885 In distribution
40-6850 In distribution
40-6447 In distribution
40-6818 In distribution
40-6695 In distribution
40-6868 In distribution
40-3238 In distribution
40-6839 In distribution
40-6844 In distribution
40-3261 In distribution
40-6862 In distribution
40-6445 In distribution
40-6075 In distribution
67-4455 In distribution
40-6848 In distribution
40-6319 In distribution
67-4509 In distribution
40-6698 In distribution
40-6058 In distribution
67-4511 In distribution
40-7189 In distribution
40-6838 In distribution
40-6901 In distribution
40-6693 In distribution
65-7241 In distribution
40-6821 In distribution
40-6803 In distribution
40-6891 In distribution
40-3233 In distribution
40-6835 In distribution
40-6017 In distribution
40-6304 In distribution
40-6694 In distribution
40-6396 In distribution
40-6382 In distribution
40-3246 In distribution
40-6389 In distribution
40-6700 In distribution
40-6444 In distribution
40-6795 In distribution
40-6907 In distribution
40-6799 In distribution
40-6794 In distribution
40-3242 In distribution
40-3263 In distribution
40-6860 In distribution
40-6859 In distribution
40-6391 In distribution
40-6074 In distribution
40-6825 In distribution
40-6385 In distribution
40-6346 In distribution
40-6800 In distribution
67-4454 In distribution
40-6056 In distribution
67-4510 In distribution
40-6336 In distribution
40-6344 In distribution
40-6103 In distribution
40-6923 In distribution
40-6804 In distribution
40-6386 In distribution
40-6394 In distribution
40-6897 In distribution
40-6899 In distribution
40-3248 In distribution
40-6446 In distribution
40-6692 In distribution
67-4504 In distribution
40-6853 In distribution
40-6691 In distribution
40-3236 In distribution
40-6820 In distribution
40-6051 In distribution
40-6100 In distribution
40-6318 In distribution
40-6871 In distribution
40-6845 In distribution
41-1338 In distribution
40-6865 In distribution
40-6076 In distribution
40-6101 In distribution
40-6314 In distribution
40-3254 In distribution
40-6843 In distribution
40-7191 In distribution
40-3232 In distribution
40-6829 In distribution
40-6895 In distribution
40-6870 In distribution
40-6851 In distribution
40-6863 In distribution
40-6302 In distribution
40-6796 In distribution
67-4508 In distribution
40-6397 In distribution
40-6880 In distribution
40-6920 In distribution
40-6696 In distribution
41-1335 In distribution
40-6894 In distribution
40-3260 In distribution
40-6832 In distribution
40-3235 In distribution
40-6921 In distribution
40-3237 In distribution
40-6904 In distribution
40-6791 In distribution
40-6922 In distribution
40-6052 In distribution
40-6866 In distribution
40-6441 In distribution
40-6440 In distribution
40-6014 In distribution
40-6078 In distribution
40-6847 In distribution
40-6831 In distribution
40-6053 In distribution
40-3234 In distribution
40-7192 In distribution
40-5989 In distribution
40-6102 In distribution
40-6903 In distribution
40-6011 In distribution
67-4505 In distribution
40-6846 In distribution
40-6334 In distribution
40-6335 In distribution
65-7240 In distribution
40-6055 In distribution
67-4514 In distribution
40-6390 In distribution
67-4512 In distribution
67-4506 In distribution
40-6057 In distribution
40-6398 In distribution
40-3252 In distribution
40-6054 In distribution
40-6306 In distribution
40-6905 In distribution
40-6797 In distribution
93-1343 In distribution
40-6900 In distribution
40-6013 In distribution
40-3205 In distribution
40-3253 In distribution
40-6792 In distribution
67-4507 In distribution
40-3245 In distribution
40-6301 In distribution
67-4453 In distribution
40-6793 In distribution
40-6902 In distribution
40-6383 In distribution
40-7187 In distribution
40-6890 In distribution
40-6012 In distribution
40-6852 In distribution
40-6836 In distribution
40-6867 In distribution
40-6104 In distribution
40-6337 In distribution
40-6018 In distribution
40-7190 In distribution
40-6801 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 164
Life Instruments Life Instrument Corp. 131
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 103
Surtex Surtex Instruments Ltd 95
Novo Surgical Novo Surgical, Inc. 89
MSI Precision Specialty Instruments MED Saver, Inc. 86
Aesculap Aesculap AG 82
gSource Gsource, LLC. 71
Integra® Jarit® Integra LifeSciences Production Corporation 64
Orthomed Ortho-MED, Inc. 60
Boss Instruments Boss Instruments, Ltd. 53
Gouge KLS-Martin L.P. 40

Showing 12 of 77. All products under Gouge, Surgical, General & Plastic Surgery

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer